Female urinary incontinence devices

ABSTRACT

Disclosed is a female urinary incontinence-inhibiting device comprising a flexible torus including at least one slot configured to, under compression, flexibly reduce the outer diameter of the flexible torus, the flexible torus having a diameter configured to inhibit female urinary incontinence when placed in a vagina and a stabilizing element, coupled to the flexible torus, the stabilizing element having a size and position configured to stabilize the flexible torus within the vagina.

RELATED APPLICATION

This application claims the benefit under 35 USC 119(e) of U.S.Provisional Patent Application 61/006,927 filed on Feb. 6, 2008, thedisclosure of which is incorporated herein by reference.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to devicesand methods for treating female urinary incontinence and, moreparticularly but not exclusively, to female incontinence treatment kitsincluding devices that aid in inserting and/or removing female urinaryincontinence devices.

Female stress urinary incontinence, the involuntarily loss of urine, mayoccur during normal movements including laughing, coughing, sneezing,exercise and any physical activity that causes an increase inintra-abdominal pressure to cause inappropriate opening of the urethra.

Inappropriate opening of the urethra is related to weakened muscles andpelvic tissues that are unable to adequately support the urethra in itscorrect position and may result from repetitive straining of the pelvicmuscles, childbirth, and loss of pelvic muscle tone.

Female stress urinary incontinence is embarrassing and unpredictable,causing afflicted women to avoid many common activities and even socialsituations.

Devices which insert into the vagina to press against the bladder neckand the urethra and control incontinence are known. Vaginally inserteddevices are normally prescribed and fitted by a health care professionaland require regular visits to a health care professional for assessment.

US Patent Publication 2004/0249238 (Farrell) teaches an incontinenceinhibiting device having a solid handle and solid round base and ishereby included by reference as if fully disclosed herein.

SUMMARY OF THE INVENTION

According to an aspect of some embodiments of the present inventionthere is provided a female urinary incontinence-inhibiting devicecomprising a flexible torus including at least one slot configured to,under compression, flexibly reduce the outer diameter of the flexibletorus, the flexible torus having a diameter configured to inhibit femaleurinary incontinence when placed in a vagina and a stabilizing element,coupled to the flexible torus, the stabilizing element having a size andposition configured to stabilize the flexible torus within the vagina.

In some embodiments of the invention, the stabilizing element comprisesat least two flexible posts.

In some embodiments of the invention, the at least two flexible postsare symmetrically arranged around the flexible torus.

In some embodiments of the invention, the at least two flexible postsare flexibly joined.

In some embodiments of the invention, the stabilizing element includes achannel through which a string extends.

In some embodiments of the invention, the flexible torus includes spokesforming a channel through which the string passes.

In some embodiments of the invention, the flexible torus includes spokesforming a receptacle and the string includes a coupling end thatremovably attaches to the receptacle.

In some embodiments of the invention, the device is included in a kitincluding an insertion handle having at least two connectors configuredto removably connect to the flexible torus.

In some embodiments of the invention, a downward surface of the flexibletorus includes a downwardly projecting ring.

In some embodiments of the invention, the device is included in a kitincluding a handle having a hook, the hook configured to removablysurround at least a portion of the downwardly projecting ring.

In some embodiments of the invention, the downwardly projecting ring isoff-center to a longitudinal axis running through the stabilizingelement.

In some embodiments of the invention, the device is included in a kitincluding a handle having a hook, the hook configured to removablysurround at least a portion of the downwardly projecting ring.

In some embodiments of the invention, the device includes an elongatereceptacle parallel to a longitudinal axis of the stabilizing element,the elongate receptacle configured to be slidingly loaded onto anelongate insertion handle.

In some embodiments of the invention, the device is included in a kitincluding an insertion tube having an elongate tip configured to slideinto the elongate receptacle.

In some embodiments of the invention, the kit additionally includes ahandle having a hook configured to removably surround at least a portionof the downwardly projecting ring.

According to another aspect of some embodiments of the present inventionthere is provided a female urinary incontinence-inhibiting device,comprising a round element having a circumference with a diameterconfigured to inhibit female urinary incontinence when placed in avagina, the round element including a coupling aperture of sufficientsize to allow insertion of an average finger of a female; andstabilizing element extending from an upper surface of the round elementand configured to stabilize the position of the round element within thevagina.

In some embodiments of the invention, the center of the couplingaperture is aligned with the axial axis of the round element.

In some embodiments of the invention, the center of the couplingaperture is unaligned with the axial axis of the round element.

In some embodiments of the invention, the device is included in a kitincluding an insertion handle having at least two connectors, eachconnector configured to each removably connect to the round element.

In some embodiments of the invention, the device includes a stringextending downwardly from the round element.

In some embodiments of the invention, the stabilizing element includes achannel through which the string extends.

In some embodiments of the invention, the round element includes spokesforming a channel through which the string passes.

In some embodiments of the invention, the spokes form a receptacle andthe string includes a coupling end that removably attaches to thereceptacle.

In some embodiments of the invention, the stabilizing element comprisesa wall surrounding a cavity, the cavity being contiguous with at least aportion of the coupling aperture.

In some embodiments of the invention, the device includes a ringprojecting downwardly from a downward surface of the round element.

In some embodiments of the invention, the device is included in a kitincluding a handle having a hook, the hook configured to removablysurround at least a portion of the ring.

In some embodiments of the invention, the ring is centered over alongitudinal axis running through the stabilizing element.

In some embodiments of the invention, the ring is off-center from alongitudinal axis running through the stabilizing element.

In some embodiments of the invention, the insertion element comprises acoupling tip.

According to another aspect of some embodiments of the present inventionthere is provided a female urinary incontinence-inhibiting device,comprising a round element having a circumference of a diameterconfigured to inhibit female urinary incontinence when placed in avagina, the round element the device includes a coupling aperture ofsufficient size to allow insertion of an average finger of a female; anda coupling element slidingly engaged in the coupling aperture.

In some embodiments of the invention, the device includes a stabilizingelement extending from an upper surface of the round element andconfigured to stabilize the position of the round element within thevagina.

In some embodiments of the invention, the stabilizing element includesan elongate receptacle configured to be slidingly engaged by thecoupling element.

In some embodiments of the invention, the stabilizing element includesan elongate receptacle configured to be slidingly loaded onto anelongate insertion handle.

In some embodiments of the invention, the device is included in a kitincluding an insertion tube having an elongate tip configured to slideinto the coupling element.

In some embodiments of the invention, the device includes a ring.

In some embodiments of the invention, the kit additionally includes ahandle having a hook configured to removably surround at least a portionof the ring.

In some embodiments of the invention, the stabilizing element includes aradially outwardly projecting curvature located a distance from theround element.

In some embodiments of the invention, the distance between the outwardlyprojecting curvature and the round element is sufficient to encouragevaginal tenting between the outwardly projecting curvature and the roundelement.

In some embodiments of the invention, the stabilizing element comprisesat least two flexible posts.

In some embodiments of the invention, each of the at least two flexibleposts include an upper prong configured for insertion into an insertiontube.

In some embodiments of the invention, the device is included in a kitincluding an insertion tube configured to hold each of the prongs in acompact configuration during insertion.

In some embodiments of the invention, the at least two flexible postsare joined below the radially outwardly projecting curvature.

In some embodiments of the invention, the round element comprises atleast one slot configured to, under compression, flexibly reduce theouter diameter of the round element for insertion into the vagina.

In some embodiments of the invention, the round element includes ametallic receptacle configured to magnetically connect to a magnetic tipof an insertion handle.

In some embodiments of the invention, the device is included in a kitincluding an insertion handle having a magnetic tip configured tomagnetically connect to the magnetized receptacle.

In some embodiments of the invention, the insertion handle additionallyincludes a connector rod configured to removably connect to the roundelement.

In some embodiments of the invention, the device includes a ringprojecting downward from the round element, the ring being off-center toa longitudinal axis of the stabilizing element.

In some embodiments of the invention, the kit additionally includes ahandle having a hook, the hook configured to removably surround at leasta portion of the ring.

According to still another aspect of some embodiments of the presentinvention there is provided a female urinary incontinence-inhibitingdevice, comprising a stabilizing element comprising a cone; and asubstantially solid round base connected to the wide portion of thecone, the round base having an outer diameter configured fit in a vaginaand inhibit female urinary incontinence, the round base furtherincluding at least one channel therethrough, the at least one channelhaving an average cross section diameter sufficient to allow passage offemale secretions when the device is positioned in a vagina.

In some embodiments of the invention, the at least one channel comprisesa tubular passage parallel to the longitudinal axis of the cone.

In some embodiments of the invention, the at least one channel comprisesa groove positioned radially around the circumference of the round base.

According to a further aspect of some embodiments of the presentinvention there is provided a female urinary incontinence inhibitingdevice comprising a round base having an outer diameter configured forinsertion into the vagina and inhibiting female urinary incontinence; astabilizing element, extending upwardly from an upward surface of theround base and configured to stabilize the position of the round basewithin the vagina; and a string extending downwardly from a downwardsurface of the round base.

In some embodiments of the invention, the stabilizing element includes acoupling projection and the string includes a looped portion configuredto loop around the coupling projection.

In some embodiments of the invention, the round base includes a stringreceptacle and the string includes a coupling configured to removablyconnect to the string receptacle.

In some embodiments of the invention, the round base includes a latchconfigured to receive a looped portion of the string.

In some embodiments of the invention, the latch comprises a flexiblepost and semicircular element, the flexible post being configured tomoveably connect the semicircular element.

According to another aspect of some embodiments of the present inventionthere is provided a female urinary incontinence inhibiting devicecomprising a stabilizing element; two round elements extending from thestabilizing element, comprising a first round element located a distancefrom a second round element, wherein the first round element has adiameter configured to inhibit female urinary incontinence when placedin a vagina.

In some embodiments of the invention, the stabilizing element extendsaxially with respect to the first round element.

In some embodiments of the invention, the second round element comprisesa diameter configured to anchor the device in the vagina.

In some embodiments of the invention, the distance between the two roundelements is sufficient to encourage vaginal tenting.

According to an additional aspect of some embodiments of the presentinvention there is provided a method for manufacturing a female urinaryincontinence device, the method comprising forming a torus having anouter diameter configured to press radially outwardly such that, whenplaced in a vagina, a portion of the vagina is pressed against a portionof the urinary tract, thereby inhibiting female urinary incontinence,extending a stabilizing element axially upwardly from an upper surfaceof the torus, extending a ring downwardly from a lower surface of thetorus, the ring being off center to the axis of the torus, forming anaxial channel through a portion of the stabilizing element, and forminga rod configured to pass into the axial channel.

Unless otherwise defined, all technical and/or scientific terms usedherein have the same meaning as commonly understood by one of ordinaryskill in the art to which the invention pertains. Although methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of embodiments of the invention, exemplarymethods and/or materials are described below. In case of conflict, thepatent specification, including definitions, will control. In addition,the materials, methods, and examples are illustrative only and are notintended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments of the invention are herein described, by way ofexample only, with reference to the accompanying drawings, With specificreference now to the drawings in detail, it is stressed that theparticulars shown are by way of example and for purposes of illustrativediscussion of embodiments of the invention. In this regard, thedescription taken with the drawings makes apparent to those skilled inthe art how embodiments of the invention may be practiced.

In the drawings:

FIGS. 1A, 1B, 2A, 2B and 2C show a slotted ring female urinaryincontinence device, insertion devices and method for insertion,according to embodiments of the present invention;

FIGS. 3, 4, 5A and 5B show string insertable female urinary incontinencedevices, according to embodiments of the present invention;

FIGS. 6A-6B show a magnetic female urinary incontinence devices andinsertion device, according to embodiments of the present invention;

FIGS. 7A, 7B, 8A, 8B and 8C show a hollow female urinary incontinencedevice and an insertion device, according to embodiments of the presentinvention;

FIG. 9 shows the female urinary incontinence device of FIG. 8A and analternative removal device, according to embodiments of the presentinvention;

FIGS. 10A, 10B, 10C and 10D show alternative configurations of femaleurinary incontinence devices, according to embodiments of the presentinvention;

FIGS. 11A-11B show an anchoring configuration of a female urinaryincontinence device, according to embodiments of the present invention;and

FIGS. 12A, 12B, 13, 14, 15, 16, 17, 18A, 18B, 19A, 19B, 20A, 20B, 21Aand 21B show alternative configurations of female urinary incontinencedevices, according to embodiments of the present invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to devicesand methods for treating female urinary incontinence and, moreparticularly but not exclusively, to female incontinence treatment kitsincluding devices that aid in inserting and/or removing female urinaryincontinence devices.

There are thus provided configurations of female urinary incontinencedevices that insert into a vagina and are configured to place pressurethrough the vaginal wall against a urethra, thereby inhibiting and/orpreventing female urinary incontinence.

In some embodiments, the female urinary incontinence device includes around base made up of separate multiple semi-circular sections that areconnected to flexible stabilizing posts, axially extending upward fromthe round base and radially inward to form a cone shape.

The flexible stabilizing posts allow movement of the semi-circularsections so that the overall diameter of the round base adjusts to thespace provided between the vaginal walls, thereby affording a better fitand/or greater comfort to the user during usage.

In further embodiments, the female urinary incontinence device includesa torus having a contiguous round base with a central space, therebyallowing a user to place the device on a finger during insertion.

In some embodiments, the torus configuration includes an off-center, lowbulk retrieval ring, allowing easy retrieval without impeding insertionof the user finger into the device during insertion into the vagina.

In still further embodiments, secretion aiding female urinaryincontinence devices are presented in which the device includes passagesthat allow passage of female secretions, thereby adding to user comfort.

In some configurations of secretion aiding female urinary incontinencedevices, the round base includes channels allowing secretion passage. Inother configurations, the round base includes grooves around the outerperimeter, forming radially outward projecting petals that maintainpressure against the vaginal walls while the grooves allow secretions topass.

In general, the vaginal walls hug a female urinary incontinence devicein a configuration often referred to as “tenting”, whereby the vaginalwalls form a tent-like configuration around cone and round base of thefemale urinary incontinence device. Presented are a variety of femaleurinary incontinence devices that take advantage of vaginal tenting toprovide increase traction and less chance of expulsion during use.

In some embodiments, the female urinary incontinence device includes anextra ring around the cone, the extra ring providing additional tractionagainst dislodgement.

In other embodiments, a female urinary incontinence device is presentedin which stabilizing elements project from a round base. Each of thestabilizing elements include a radially outwardly projecting curvature.

The stabilizing posts contract during insertion and expand followingplacement. In the expanded configuration, the outward pressure of thecurved post portions pressing against the tented vagina provide frictionand resistance against displacement.

In further embodiments, the stabilizing elements are free standing andinclude upper prongs configured to insert into an insertion tube. Theinsertion tube is configured to hold the stabilizing elements in acompact configuration during insertion. Following insertion, theinsertion tube is removed and the stabilizing elements resiliently bendradially outward to lodge in the tented vaginal walls.

In still further embodiments the stabilizing elements are adjoined justbelow the radially outwardly projecting curvatures so that the portionsof the stabilizing elements extending upward of the adjoined portionsflex radially inward during insertion.

Further embodiments of the invention include additional aids forinsertion and/or removal of female urinary incontinence devices.

For example, in some embodiments, the female urinary incontinence deviceincludes a receptacle configured to be slidingly loaded onto an elongateinsertion handle. The female urinary incontinence device is included ina kit with a handle having a coupling end configured to slidingly insertinto the receptacle on the female urinary incontinence device.

In still further embodiments, the female urinary incontinence device isincluded in a kit and is presented along with a handle having a magnetictip. A metallic port on the female urinary incontinence device isconfigured to receive the magnetic tip so that during removal, the usercan easily align the handle and remove the female urinary incontinencedevice.

In still further embodiments, a string is connected to the round base ofthe female urinary incontinence device to facilitate removal. In furtherembodiments, the string is removably connected to the round base and theuser may change to a new string after every use or after several uses.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not necessarily limited in itsapplication to the details of construction and the arrangement of thecomponents and/or methods set forth in the following description and/orillustrated in the drawings and/or the Examples. The invention iscapable of other embodiments or of being practiced or carried out invarious ways.

Referring now to the drawings, FIG. 1A illustrates a female urinaryincontinence device 100.

Slotted Female Urinary Incontinence Device

Female urinary incontinence device 100 including a blunt nose 102, acone 116 comprising multiple resilient posts 104 and a round base 130comprising multiple semi-circular sections 106 situated around a cavity140 that facilitates easy manipulation of female urinary incontinencedevice 100 with a user finger.

The resilience of posts 104 allow movement of semi-circular sections 106such that the overall diameter of round base 130 adjusts so that a usermay be provided with a proper fit and/or proper comfort level byensuring proper adjustment to vaginal dimensions.

In some embodiments there are at least two and no more than eightmultiple ring sections 106, each connected to one or more posts 104.

There are many devices configured for facilitating insertion of femaleurinary incontinence device 100.

Insertion of Slotted Female Urinary Incontinence Device

FIG. 1B shows female urinary incontinence device 100 loaded on aninsertion device 120 having multiple insertion prongs 108 that grasp andstabilize round base 130. While only two insertion prongs 108 are shown,insertion device 120 is contemplated with three, four, six or even eightinsertion prongs 108.

FIGS. 2A-2C show insertion of female urinary incontinence device 100into a vagina 112. Typically, female urinary incontinence device 100 andvagina 112 are each first lubricated with, for example, a water solublelubricant.

The labia of the vulva is separated and female urinary incontinencedevice 100 inserted into vagina 112 using, for example, insertion device120 and pushed to a position where the incontinence inhibiting deviceoutwardly presses against internal wall of vagina 112 to support aurethra 114 and/or a bladder neck 117. The pressure applied by femaleurinary incontinence device 100 limits or prevents involuntary passageof urine through urethra 114, thereby inhibiting or preventing femaleurinary incontinence.

Prongs 108 and round base 130 are typically a flexible material, so thatonce female urinary incontinence device 100 is in place, friction fromvagina 112 holds onto female urinary incontinence device 100, andinsertion device 120 can be pulled out of vagina 112 with female urinaryincontinence device 100 remaining in place.

In order to remove female urinary incontinence device 100, the labia ofthe vulva are separated, insertion device 120 is pressed into vagina 112until prongs 108 grasp the periphery (or internal part) of round base130 and urinary incontinence device 100 is pulled out of vagina 112.

In some embodiments, insertion device 120 and/or female urinaryincontinence device 100 are non-disposable. As in all configurationspresented, female urinary incontinence device 100 may be cleanedperiodically and used multiple times. Alternatively, female urinaryincontinence device 100 may be disposed of and replaced following asingle use or even multiple uses.

Urinary incontinence device 100 allows voluntary urination and may beleft in place during normal day-to-day activities, overnight and forseveral days. Urinary incontinence device 100 may be manually inserted,repositioned, and removed by a user; thereby possibly eliminatingfrequent visits to health care professionals in many cases.

Urinary incontinence device 100 may be manufactured in a plurality ofsizes and any number of incontinence inhibiting or prevention devices ofvarying dimensions could be provided as a set or otherwise.

String Female Urinary Incontinence Devices

FIG. 3 shows a female urinary incontinence device 200 wherein round base130 comprises a solid disk 210 with an application string 202 extendingtherefrom.

Application string 202 can be used to assist pulling the female urinaryincontinence device 200 during its removal.

FIG. 4 shows female urinary incontinence device 200 in which applicationstring 202 includes a coupling end 204 that removably inserts into acoupling channel 262, allowing the user to change application string 202following removal, thereby allowing for use of a fresh string duringevery use, or periods of use. In embodiments, coupling end 204 may be inhave a form of a screw or a drawing pin, referred to as a tucker.

FIGS. 5A-5B show female urinary incontinence device 200 in whichapplication string 202 includes a loop 208 that passes through a latch206 attached to round base 130, Removal of loop 208 is accomplished bysqueezing latch 206 to disengage a post 234 from a hook 232 so that loop208 can pass through the gap created thereby.

In some instances, a user may prefer using a system including a handlethat aids in both insertion and removal of female urinary incontinencedevice.

Magnetic Female Urinary Incontinence Device and Insertion Device

FIGS. 6A-6B show a system including a magnetic female urinaryincontinence device 250 comprising an applicator guide 220 having amagnetic tip 222 and round base 130 including a metal-lined port 224.

During removal of magnetic female urinary incontinence device 250, theuser inserts applicator guide 220 near round base 130 and magnetic tip222 is magnetically guided into port 224.

After magnetic tip 222 is in port 224, the user presses a button 230that pushes on a hookup rod 238 to grasp port 224 so that magneticfemale urinary incontinence device 250 may be removed in spite of thefunction of provided by the above-noted tenting.

In some instances, female urinary incontinence device 250, with cone 116that is solid may cause discomfort to some users and/or prevent a userfrom inserting a finger to guide female urinary incontinence device 250into place. A variety of flexible and/or hollow configurations of femaleurinary incontinence device 250 are presented herein.

Hollow Female Urinary Incontinence Device

FIGS. 7A-7B show a hollow female urinary incontinence device 260 whereinround base 130 comprises a wall 240 that is hollow to reduce rigidityand possibly increase user comfort. Additionally or alternatively, coneportion 130 may comprise hollow wall 240 to further increase usercomfort.

Additionally, hollow female urinary incontinence device 260 optionallyincludes a low bulk application ring 214 that is easily grasped by theuser during application.

In some instances a user may prefer using an insertion device withhollow female urinary incontinence device 260, while using low bulkapplication ring 214 for removal; and the following embodiments arepresented to possibly satisfy this preference.

Insertion Device for Hollow Female Urinary Incontinence Device

FIGS. 8A-8C show insertion handle 220 having a coupling end 228 thatinserts into a coupling channel 266 of hollow female urinaryincontinence device 260.

Following positioning of hollow female urinary incontinence device 260,insertion handle 220 is pulled to slide coupling end 220 out of couplingchannel 266.

To accommodate the axial position of coupling end 228, low bulkapplication ring 214 has been moved off-center to the longitudinal axisof hollow female urinary incontinence device 260.

In some embodiments, hollow female urinary incontinence device 260includes round base 130 comprising a torus having an inner diameter thatis large enough to fit on an index finger. In such configurations,hollow female urinary incontinence device 260 may be pushed into place,aligned and/or removed while sitting on the index finger.

Some users may prefer using a device to remove hollow female urinaryincontinence device 260 rather than directly grasping application ring214; the following embodiment address this preference:

Removal Device for Hollow Female Urinary Incontinence Device

FIG. 9 shows a removal handle 225 including a hook 245 that is coupledto low bulk application ring 214 and can be used to easily remove hollowfemale urinary incontinence device 260 from the user.

Blocking the flow of vaginal secretions may present a problem during useof female urinary incontinence devices. The following embodimentsaddress such issues:

Secretion Aiding Female Urinary Incontinence Insertion Devices

FIGS. 10A-10B show a female urinary incontinence device 300 comprisingsecretion passages 251 in round base 130 that is substantially solid.Secretion passages 251 are of a size that allows passage of femalesecretions.

FIGS. 10C-10D show a female urinary incontinence device 360 comprisingsecretion grooves 218 in round base 130 for allowing passage of femalesecretions.

In some instances, a user may have exceptionally weak musculature that,unfortunately, allows displacement or expulsion of female urinaryincontinence insertion device 360, for example during a sneeze or cough.The following embodiments provide an anchoring configuration thataddresses such displacement problems.

Anchoring Female Urinary Incontinence Devices

FIGS. 11A-11B show an anchoring female urinary incontinence device 320comprising a solid anchor ring 236 along cone 116 which is solid aswell. Solid anchor ring 236 provides additional friction against vaginalwall 112 as seen in FIG. 2C, so that the tenting effect of vaginal wallis pronounced, thereby providing increased anchoring.

Open Prong Female Urinary Incontinence Device

FIGS. 12A-13 show an open prong female urinary incontinence device 340in which posts 104 are resilient and free standing, meaning unattached,for example, to nose 102 (FIG. 1A). Additionally, each of posts 104include an upper curvature 280 that extends radially outward. Uppercurvatures 280 extend into vaginal walls 112 (FIG. 2C) to provideincreased resistance against displacement.

As seen in FIG. 12B, control prongs 342 are spaced a distance from thelongitudinal axis of female urinary incontinence device 340.

As seen in FIG. 13, when open prong female urinary incontinence device340 is loaded on an inserter handle 350, control prongs 342 are pushedinto an inserter tube, thereby reducing the distance between controlprongs and causing posts 104 to resiliently bend radially inwardly,hence forming a compact end that facilitates easy and smooth insertion.

Following insertion, inserter handle 350 is removed, freeing controlprongs 342 from an inserter tube 352 allowing posts 104 to resilientlybend radially outward. The outward thrust of posts 104 presses againstthe tenting configuration of vaginal walls 112 (FIG. 2C), therebyincreasing friction and resistance against displacement.

In some instances, a user might prefer a device that, similar to openprong female urinary incontinence device 340, takes advantage of tentingconfiguration, but does not include posts 104 that resiliently bendradially outward.

Closed Prong Female Urinary Incontinence Device

FIGS. 14-16 show closed prong female urinary incontinence devices 340 inwhich posts 104 are joined at a core 344, thereby facilitating insertionand preventing radially outward movement of posts 104, and providingincreased friction to resist displacement.

FIG. 14 shows closed prong female urinary incontinence device 340including multiple semi-circular sections 106.

FIG. 15 shows closed prong female urinary incontinence device 340including a solid torus 249 surrounding an instrument insertion cavity242, while FIG. 16 shows an inserter handle 350 passing throughinstrument insertion cavity 242 prior to application.

FIG. 17 shows female urinary incontinence device 100 including solidtorus 249 surrounding instrument insertion cavity 242.

There are many additional configurations of female urinary incontinencedevices that may be preferred by users due to ease of insertion and/orremoval or even aesthetic considerations; and the following embodimentsaddress such preferences.

Alternative Configurations of Female Urinary Incontinence Devices

FIGS. 18A-21B show alternative configurations of guiding devices forfemale urinary incontinence device 100.

FIGS. 18A-18B show string 202 anchored in a string channel 160 thatpasses through blunt nose 102 and cone 116 and exits through cavity 140between multiple semi-circular sections 106. String channel 160 servesto center string 202 so that string may pass through a hollowinstrument, for example inserter tube 352 and handle 350 (FIG. 13) tostabilize female urinary incontinence device 100 during insertion.

In some embodiments, string 202 may be removably attached in stringchannel 160 to allow the user to easily change string 202 when sodesired. In further embodiments, the user may optionally insert femaleurinary incontinence device 100 without string 202.

FIGS. 19A-19B show an anchor button 172 projection to which applicationstring 202 is attached.

FIGS. 20A-20B show coupling end 204 that inserts into a coupling passage180 between multiple spokes 182 to anchor string 202 to female urinaryincontinence device 100.

FIGS. 21A-21B show female urinary incontinence device 100 with low bulkapplication ring 214.

It is expected that during the life of a patent maturing from thisapplication many relevant female urinary incontinence devices will bedeveloped and the scope of the term female urinary incontinence deviceis intended to include all such new technologies a priori.

As used herein the term “about” refers to ±10%.

The terms “comprises”, “comprising”, “includes”, “including”, “having”and their conjugates mean “including but not limited to”.

The term “consisting of” means “including and limited to”.

As used herein, the singular form “a”, “an” and “the” include pluralreferences unless the context clearly dictates otherwise. For example,the term “a compound” or “at least one compound” may include a pluralityof compounds, including mixtures thereof.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

As used herein the term “method” refers to manners, means, techniquesand procedures for accomplishing a given task including, but not limitedto, those manners, means, techniques and procedures either known to, orreadily developed from known manners, means, techniques and proceduresby practitioners of the chemical, pharmacological, biological,biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantiallyinhibiting, slowing or reversing the progression of a condition,substantially ameliorating clinical or aesthetical symptoms of acondition or substantially preventing the appearance of clinical oraesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments, may also beprovided in combination in a single embodiment. Conversely, variousfeatures of the invention, which are, for brevity, described in thecontext of a single embodiment, may also be provided separately or inany suitable subcombination or as suitable in any other describedembodiment of the invention. Certain features described in the contextof various embodiments are not to be considered essential features ofthose embodiments, unless the embodiment is inoperative without thoseelements.

Although the invention has been described in conjunction with specificembodiments thereof it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting.

1. A female urinary incontinence-inhibiting device, comprising: i) atorus having a diameter configured to inhibit female urinaryincontinence when placed in a vagina; and ii) a generally taperingstabilizing element, coupled to said torus, said stabilizing elementhaving a size and position configured to stabilize said torus within thevagina, wherein said device defines at least one channel therethrough,said at least one channel having an average cross section diametersufficient to allow passage of female secretions when said device ispositioned in a vagina.
 2. The device according to claim 1, wherein saidat least one channel comprises a tubular passage parallel to thelongitudinal axis of said stabilizing element.
 3. The device accordingto claim 1, wherein said at least one channel comprises a groove in saidtorus.
 4. The device according to claim 1, wherein said torus is aflexible torus and comprises at least one slot configured to, undercompression, flexibly reduce the outer diameter of said torus forinsertion into the vagina.
 5. The device according to claim 1, whereinsaid stabilizing element includes a channel through which a stringextends.
 6. The device according to claim 5, wherein said torus includesspokes forming a channel through which said string passes.
 7. The deviceaccording to claim 6, wherein said torus includes spokes forming areceptacle and said string includes a coupling end that removablyattaches to said receptacle.
 8. The device according to claim 1,provided as part of a kit including an insertion handle having at leasttwo connectors configured to removably connect to said torus.
 9. Thedevice according to claim 1, wherein a downward surface of said torusincludes a downwardly projecting ring.
 10. The device according to claim9, provided as part of a kit including a handle having a hook, said hookconfigured to removably surround at least a portion of said downwardlyprojecting ring.
 11. The device according to claim 9, wherein saiddownwardly projecting ring is off-center to a longitudinal axis runningthrough said stabilizing element.
 12. The device according to claim 1,including an elongate receptacle parallel to a longitudinal axis of saidstabilizing element, said elongate receptacle configured to be slidinglyloaded onto an elongate insertion handle.
 13. The device according toclaim 12, comprising a kit including an insertion tube having anelongate tip configured to slide into said elongate receptacle.
 14. Adevice according to claim 1, including a coupling aperture of sufficientsize to allow insertion of an average finger of a female.
 15. The deviceaccording to claim 14, wherein the center of said coupling aperture isaligned with the axial axis of said torus.
 16. The device according toclaim 14, wherein the center of said coupling aperture is unaligned withthe axial axis of said torus.
 17. The device according to claim 1,including an additional stabilizing element extending from an uppersurface of said torus and configured to stabilize the position of saidtorus within the vagina.
 18. The device according to claim 1, whereinsaid stabilizing element includes a radially outwardly projectingelement located a distance from said torus.
 19. The device according toclaim 18, wherein said distance between said outwardly projectingelement and said torus is sufficient to encourage vaginal tentingbetween said outwardly projecting curvature and said torus.
 20. Thedevice according to claim 18, wherein said radially outward projectingelement comprises a ring.
 21. The device according to claim 1, whereinsaid stabilizing element comprises at least two flexible posts.
 22. Thedevice according to claim 21, wherein each of said at least two flexibleposts include an upper prong configured for insertion into an insertiontube.
 23. The device according to claim 22, provided as part of a kitincluding an insertion tube configured to hold each of said prongs in acompact configuration during insertion.
 24. The device according toclaim 17, wherein said torus includes a metallic receptacle configuredto magnetically connect to a magnetic tip of an insertion handle.
 25. Adevice according to claim 1, wherein said device is a substantiallyvoidless solid.
 26. A device according to claim 1, comprising at leasttwo round elements extending from said stabilizing element, comprising afirst round element located a distance from a second round element,wherein said first round element has a diameter configured to inhibitfemale urinary incontinence when placed in a vagina.
 27. The deviceaccording to claim 26, wherein said distance between said two roundelements is sufficient to encourage vaginal tenting.
 28. The deviceaccording to claim 1, wherein said stabilizing element has a resilientsurface which, for at least 70% of positions along an axis perpendicularto said torus, encircles said axis contiguously.
 29. The deviceaccording to claim 1, wherein said stabilizing element has a conicalsurface.